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L.5.01.510
Noritate (metronidazole)
Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
Rosacea is a chronic, inflammatory facial skin disorder of unknown cause. The hallmark of rosacea is central facial persistent erythema, typically affecting the cheeks, chin, forehead, and nose. The goal of therapy is to manage the clinical signs and physical symptoms of rosacea.
Noritate 1% (metronidazole cream) is indicated for the topical treatment of inflammatory lesions and erythema of rosacea.
Prior authorization is required.
The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.
Initial Criteria
Noritate (metronidazole cream) may be considered medically necessary when ALL of the following criteria are met:
Individual has a documented diagnosis of rosacea; AND
Individual has tried and failed (see Failure in Policy Guidelines) TWO formulary topical metronidazole agents (e.g., metronidazole 0.75% cream, metronidazole 0.75% gel, metronidazole 0.75% lotion, metronidazole 1% gel, Rosadan).
Length of Approval: 12 months
Renewal Criteria
Noritatemay be considered for renewal when ALL of the follow criteria are met:
Individual has previously been approved for therapy through BCBSMS PA process; AND
Individual is responding positively to therapy.
Length of Approval: 12 months
State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medication failure is defined as disease progression despite maximally tolerated dose (>1 months use) as appropriate for disease state being treated. Experience of common side effects of medication will not be considered medication failure for the purpose of this review.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [ie, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
02/14/2017: New policy added. Policy number L.5.01.510.
05/16/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
02/06/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
04/01/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy title and description updated to change "Noritate® (metronidazole cream)" to "Noritate 1% (metronidazole cream)." Added policy statement that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Sources section updated.
11/01/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added drug name to the top of the policy. Policy description updated regarding rosacea. Medically necessary statement updated to list examples of topical metronidazole agents. Added renewal criteria. Policy Exceptions updated to remove FEP and State Health Plan members. Policy Guidelines updated to define medication failure and investigative. Changed "Nervous/Mental Conditions" to "Mental Health Disorders." Sources updated.
02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
03/20/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Policy statements updated to change "Member" to "Individual." Sources updated.
Del Rosso, James Q et al. “Update on the Management of Rosacea from the American Acne & Rosacea Society (AARS).” The Journal of clinical and aesthetic dermatology vol. 12,6 (2019): 17-24.
Noritate 1% prescribing information. Bausch Health US, LLC. June 2020. Last accessed February 2025.
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